CN104414777A - Radioactive bracket for treating malignant tumor of digestive tract and preparation method thereof - Google Patents
Radioactive bracket for treating malignant tumor of digestive tract and preparation method thereof Download PDFInfo
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- CN104414777A CN104414777A CN201310372723.XA CN201310372723A CN104414777A CN 104414777 A CN104414777 A CN 104414777A CN 201310372723 A CN201310372723 A CN 201310372723A CN 104414777 A CN104414777 A CN 104414777A
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Abstract
The invention belongs to the fields of biomedicine and high polymer material, and relates to a radioactive bracket for treating malignant tumor of digestive tract and the preparation method thereof. The bracket combines the radionuclide with the molecular surface of a degradable material, so as to produce radioactive biodegradation brackets of different concentrations for treating malignant tumor of digestive tract; the radioactive bracket for treating malignant tumor of digestive tract consists of a digestive tract bracket, an inner layer, an outer layer and positioning tube sleeves; the digestive tract bracket is coated with the inner layer, bilateral sides of the inner layer are provided with the positioning tube sleeves, and the outer layer wraps the inner layer and the positioning tube sleeves, wherein the inner layer is prepared by the mixture of a biocompatible high polymer material and a radioactive substance, the outer layer is a biocompatible high polymer material, and the positioning tube sleeves are made of stainless steel. The bracket can not only ensure the effective drainage of bile and pancreatic juice, but also treat the tumor with the locally precise radiotherapy effect; the bracket is safe, reliable, low cost, simple in preparation method, strong in practicability, and favorable application prospect.
Description
Technical field
The invention belongs to biomedical sector and polymeric material field, relate to a kind of radiant stand for the treatment of malignant tumor of digestive tract and preparation method thereof.
Background technology
Radiopharmaceutical, as a kind of base therapy method, is widely used in clinical practice both domestic and external; Especially closely internal radiotherapy malignant tumor, have the advantages such as simple to operate, therapeutic effect is good, clinical practice shows wide prospect.
Known at present, malignant tumor of digestive tract companion is narrow is clinical common disease, and have very high sickness rate, be the great difficult problem perplexing numerous medical personnels always.A Grade III Class A hospital, every year because of patient about 200 ~ 300 example of digestive tract malignant stricture, digestive tract cancer and hospitalization, general not good by traditional Therapeutic Method curative effect, patient suffering is large, complication is many, relapse rate is high, many patients must treat by repeated hospitalization throughout the year, bring white elephant to family and society.Therefore, at present in the urgent need to a kind of radiant stand for the treatment of malignant tumor of digestive tract; This support adopts the preparation of iodine-125 active material, can solve the problem of pancreas digestive tract malignant stricture to a great extent, greatly alleviates economic pressures and burden on society.For malignant tumor of digestive tract with the patient of blocking, described support can not only ensure that effective digestive tract is unobstructed, and the accurate radiotherapy effect also by local is treated tumor.
But up to now, there is not yet the report of the radiant stand of associated therapy malignant tumor of digestive tract and preparation method thereof.
Summary of the invention
The object of the present invention is to provide a kind of radiant stand for the treatment of malignant tumor of digestive tract; In this radioactivity, radionuclide (as 125I) is incorporated into the molecular surface of degradation material, the obtained support that can carry out radiotherapy in local to tumor, it had both improve the systemic side effects that curative effect decreases radiotherapy, and No leakage again, cheap, safe and reliable.
Specifically, the radiant stand of this treatment malignant tumor of digestive tract, is characterized in that, is made up of alimentary stent 1, internal layer 2, skin 3 and positioning pipe sleeve 4; Described alimentary stent 1 is smeared internal layer 2, locating sleeve 4 is established in internal layer 2 both sides, described outer 3 wrapping inner layer 2 and locating sleeve 4;
In the present invention, described alimentary stent 1 adopts alimentary stent of the prior art (commercially available);
In the present invention, described internal layer 2 adopts biocompatible polymer material and radioactive substance mixture to prepare; In one embodiment of the present of invention, described internal layer 2 adopts silica gel and radioactivity iodine-125 mixture to prepare;
In the present invention, described skin 3 is biocompatible polymer material, for contained radioactivity material (as radioactivity iodine-125); In one embodiment of the present of invention, described outer 3 is silica gel;
In the present invention, described locating sleeve 4 adopts rustless steel to prepare.
In the present invention, described biocompatible polymer material is selected from any one in silica gel, latex etc., or any two copolymers of above-mentioned material, or the copolymer of three kinds;
In the present invention, described radioactive substance is the radioactive substance half-life being less than 3 months, as iodine-125.
Another object of the present invention is to provide the preparation method of the radiant stand of described treatment malignant tumor of digestive tract, the steps include:
(1) liquid-state silicon gel 1 and silica gel 2 are got two equivalent to mix in beaker;
(2) getting appropriate normal octane adds in the mixture of above-mentioned silica gel, by three's mix homogeneously, forms mixture A, stand-by;
(3) adopt the method preparating mixture B same with above-mentioned steps (2), wherein, the normal octane added in mixture B is the twice of addition in mixture A;
(4) needed by described alimentary stent both sides, labelling iodine-125 radioactive position to establish two marks I, and each 0.5-1cm place establish mark II again in the outside of these two marks I;
(5) with special elasticity pipe cap, support two ends are closed, pollute in order to avoid radioactive substance enters pancreas digestive tract inside;
(6) said mixture A, mixture B and alimentary stent are moved in the glove box with protection of sealing and (prevent from volatile iodine-125 solution from human body is produced to irradiation and produces environment to pollute);
(7) size of the iodine-125 radiant stand activity prepared as required, adds the iodine-125 solution (specific activity is greater than 800mCi/ml) of high concentration in mixture B, and again by all substances mix homogeneously;
(8) the described mixture B that takes a morsel is positioned on microscope slide;
(9) with the hands hold the two ends of described support, roll back and forth gently on the microscope slide being placed with mixture B, the mixture B smeared up does not exceed the external boundary of two marks I, and the thickness smearing mixture B is 0.2-0.3mm;
(10) above-mentioned steps (8) and (9) is repeated, by mixture B uniform application in the position that described mark 1 limits;
(11) dry being coated with the described stentplacement wiped at the temperature of 70 degree;
(12) two rustless steel pipe boxes are positioned over mark I place respectively and are close to coating, for CT scan location and postoperative CT scan inspection in performing the operation;
(13) the described mixture A that takes a morsel is placed on another block microscope slide;
(14) two ends of above-mentioned support are with the hands held, roll back and forth on the microscope slide being placed with mixture A gently, the mixture A smeared up covers between mark II, smearing thickness is 0.2-0.3mm, that is smeared first time all seals containing iodine-125 radioactivity mixed zone and rustless steel positioning pipe sleeve, prevents radioactive substance from revealing;
(15) above-mentioned steps (12) and (13) is repeated, by mixture A uniform application in the position that described mark II limits;
(16) again drying being coated with under the above-mentioned support wiped is placed on the temperature of 70 degree, making the radiant stand for the treatment of malignant tumor of digestive tract.
After the present invention adopts biocompatibility macromolecule non-degradable material to wrap up radioactive substance, make the radiolabeled biotin degraded support in order to treat malignant tumor of digestive tract of variable concentrations; This radiant stand can not only ensure effective bile, pancreatic juice drainage, and the accurate radiotherapy effect also by local is treated tumor; The catabolite of described radiant stand leaks by "dead" source, nontoxic, and radioactive substance fades away over the course for the treatment of.Radiant stand of the present invention had both had tumor in radiotherapy effect, safe and reliable, cheap again, and its preparation method is simple, and practical, application prospect is good.
For the ease of understanding, below by the drawings and specific embodiments, the present invention is described in detail.It is important to note that specific embodiments and the drawings are only to illustrate, obvious those skilled in the art according to illustrating, can carry out various correction or change to the present invention herein, and these are revised and change and also will include within the scope of the invention.
Accompanying drawing explanation
Fig. 1 is the radiant stand schematic appearance for the treatment of malignant tumor of digestive tract of the present invention, wherein,
1 be alimentary stent, 2 be internal layer, 3 for outer, 4 be positioning pipe sleeve.
Fig. 2 is the process chart of the radiant stand preparing described treatment malignant tumor of digestive tract in the present invention.
Detailed description of the invention
embodiment 1
As shown in Figure 1, the radiant stand of this treatment malignant tumor of digestive tract, is made up of alimentary stent 1, internal layer 2, skin 3 and positioning pipe sleeve 4; Described alimentary stent 1 is smeared internal layer 2, locating sleeve 4 is established in internal layer 2 both sides, described outer 3 wrapping inner layer 2 and locating sleeve 4;
Described alimentary stent 1 adopts alimentary stent of the prior art (commercially available);
Described internal layer 2 adopts silica gel and radioactivity iodine-125 mixture to prepare; Outer 3 for being silica gel, for sealing iodine-125; Locating sleeve 4 adopts rustless steel to prepare.
embodiment 2
Shown in Fig. 2, the radiant stand of preparation treatment malignant tumor of digestive tract, step is:
1, production technology
(1) prescription is produced
1. [name of product]
The radiant stand for the treatment of malignant tumor of digestive tract;
2. [dosage form and specification] treats the radiant stand of malignant tumor of digestive tract; 37 ~ 740MBq (1 ~ 20mCi); Maximum outside diameter is less than 3.5mm
3. [supplementary material inventory]
Supplementary material; Medical silica-gel 1,2; Normal octane; Radioactivity iodine-125 solution; Alimentary stent;
4. [radionuclide halflife] radionuclide halflife: T1 ∕ 2=60.1 days;
5. [purposes] is for malignant tumor of digestive tract with the patient of blocking, and support can not only ensure effective bile, pancreatic juice drainage, and the accurate radiotherapy effect also by local is treated tumor; This product is also applicable to the tumor of tumor and the recurrence remained through lonizing radiation external radiotherapy;
(2) Workplace and device therefor
1. workshop and clean area:
The workshop that iodine-125 radioactivity enteral digestion road support need have higher requirements at ventilation, filtration and preventer carries out; Last activity measurement, sub-bottle, delivery packaging need be carried out in D level clean area, and require that temperature is 18 ~ 26 DEG C, humidity is 45% ~ 65%; Non-clean area humiture has no special requirements;
The operations such as silica gel mixing, dissolving are in general production area; The operations such as radiation is prepared, smeared, baking complete in the seal box possessing air filter or ventilated chamber; Cleaning completes in ventilated chamber; The operations such as dose measurement, warehouse-in and packaging complete in D level clean area;
2. key equipment
With glove box and the ventilated chamber of air filtration and radioprotector, microscope slide, baker, rustless steel positioning pipe sleeve, appearance inspecting system, wiping filter paper, nucleic activity meter, Liquid Scintillation Analyzer, surface contamination instrument, heated at constant temperature instrument, multi-channel energy spectrometer, activity measurement instrument, air conditioning and cleaning system, other radiation-protection equipments;
2, prepare described radiant stand, as shown in Figure 2, step is in its technological process:
(1) liquid-state silicon gel 1 and silica gel 2 are got two equivalent to mix in beaker;
(2) getting appropriate normal octane adds in the mixture of above-mentioned silica gel, by three's mix homogeneously, forms mixture A, stand-by;
(3) adopt the method preparating mixture B same with above-mentioned steps (2), wherein, the normal octane added in mixture B is the twice of addition in mixture A;
(4) needed by described alimentary stent both sides, labelling iodine-125 radioactive position to establish two marks I, and each 0.5-1cm place establish mark II again in the outside of these two marks I;
(5) with special elasticity pipe cap, support two ends are closed, pollute in order to avoid radioactive substance enters pancreas digestive tract inside;
(6) said mixture A, mixture B and alimentary stent are moved in the glove box with protection of sealing and (prevent from volatile iodine-125 solution from human body is produced to irradiation and produces environment to pollute);
(7) size of the iodine-125 radiant stand activity prepared as required, adds the iodine-125 solution (specific activity is greater than 800mCi/ml) of high concentration in mixture B, and again by all substances mix homogeneously;
(8) the described mixture B that takes a morsel is positioned on microscope slide;
(9) with the hands hold the two ends of described support, roll back and forth gently on the microscope slide being placed with mixture B, the mixture B smeared up does not exceed the external boundary of two marks I, and the thickness smearing mixture B is 0.2-0.3mm;
(10) above-mentioned steps (8) and (9) is repeated, by mixture B uniform application in the position that described mark 1 limits;
(11) dry being coated with the described stentplacement wiped at the temperature of 70 degree;
(12) two rustless steel pipe boxes are positioned over mark I place respectively and are close to coating, for CT scan location and postoperative CT scan inspection in performing the operation;
(13) the described mixture A that takes a morsel is placed on another block microscope slide;
(14) two ends of above-mentioned support are with the hands held, roll back and forth on the microscope slide being placed with mixture A gently, the mixture A smeared up covers between mark II, smearing thickness is 0.2-0.3mm, that is smeared first time all seals containing iodine-125 radioactivity mixed zone and rustless steel positioning pipe sleeve, prevents radioactive substance from revealing;
(15) above-mentioned steps (12) and (13) is repeated, by mixture A uniform application in the position that described mark II limits;
(16) again drying being coated with under the above-mentioned support wiped is placed on the temperature of 70 degree, making the radiant stand for the treatment of malignant tumor of digestive tract;
(17) radiant stand of above-mentioned drying is put in vial, then vial is put into pig, shift out from glove box, proceed to lower road visual examination operation.
3, the size of radiant stand and visual examination
(1) from glove box, shift out the above-mentioned radiant stand made, the visual examination carrying out support in the ventilated chamber with protection, air draft, filtration need be proceeded to: (check the sealing of support outside dimension and trial inspection support; Wherein, visual examination is carried out in the imaging system of amplifying, and can be clear that the surface structure of support in display bottle);
(2) described radiant stand is put into rustless steel pallet, use vernier caliper measurement coating outer diameter; Wherein, its outside dimension is no more than 3.5mm; And then under pallet is positioned over photographic head together with described radiant stand, the coarse adjustment knob on adjustment photographic head, makes the display object on display enough large, then adjusts the fine tuning knob on photographic head, make display object enough clear;
(3) slowly rotate described radiant stand with tweezers, make it rolling 360 °;
(4) above-mentioned radiant stand is observed over the display; (this radiant stand surface should be smooth, sealing imporosity; Qualified radiant stand puts into the bottle posting " qualified " label, and underproof radiant stand is then put into the bottle posting " defective " label and collected together, again can prepare new radiant stand in glove box);
(5) above-mentioned steps (2) is repeated to (4), until check out all radiant stands produced; All qualified iodine-125 radiant stands are proceeded to lower road matting.
4, iodine-125 radiant stand is cleaned
(1) iodine-125 radiant stand level qualified for visual examination is put into the little tank of rustless steel; Add the cleaning solution of special clean iodine-125 nucleic in tank, liquid level must flood described radiant stand;
(tank that described iodine-125 radiant stand is housed is positioned on the adjustable heated at constant temperature instrument of temperature by 2, and the temperature arranging heated at constant temperature instrument is 70 degree, power-on;
(3) with pipettor, cleanout fluid was siphoned away every 20 minutes, put into radioactive liquid waste bottle;
(4) above-mentioned steps (3) three times are repeated, (if it is very high to exceed background level, then suspection may have leakage to the radioactive radiation level of the solution be sucked out with surface contamination analyzer measurements for the last time, needs to re-start visual examination, find out the support of leakage, more again clean; If it is not high to exceed background level, then can thinks not clean clean, again need clean and again measure, until the radiation level of sucking-off solution is low to moderate background);
(5) clean three above-mentioned qualified iodine-125 radiant stands by purified water again, wash the cleanout fluid of residual special clean iodine-125 nucleic off;
(6) dry all radiant stands, then proceed to lower road surface contamination and leak-testing operation.
5, surface contamination and the leakage of iodine-125 radiant stand is checked
(1) get a fritter wiping filter paper, carry out comprehensive wiping at the outer surface of the iodine-125 radiolabeled biotin non-degradable pancreas alimentary stent cleaned up gently;
(2) filter paper wiped across is put into liquid and dodge bottle, then add 4ml scintillation solution in bottle, and tighten bowl cover, shake up, make liquid fully soak filter paper;
(3) in measuring every bottle with the Liquid Scintillation Analyzer of Low background
125the content of I;
(4) result judges: if in every bottle
125the content of I is less than 185Bq(and 5nCi), then show that this bottle of corresponding iodine-125 radiant stand surface is not polluted and do not leak; If
125the content of I is equal to or greater than 185Bq(and 5nCi), then this iodine-125 radiolabeled biotin non-degradable pancreas alimentary stent should return last process and re-start visual examination and decontamination cleaning treatment, and then carries out surface contamination and leak check till conformance with standard.
(5) namely next procedure is proceeded to through surface contamination and the qualified iodine-125 radiant stand of leak test.
6, the equivalent activity activity of iodine-125 radiant stand is measured
(1) standard source that iodine-125 radiant stand measures nucleic activity meter is demarcated
1. before or after measuring iodine-125 radiant stand activity, all must demarcate nucleic activity meter with iodine-125 radiant stand standard source, ensure the accuracy measuring activity;
2. press described nucleic activity meter indicates aim at the measurement key that iodine-125 radiant stand carries out measuring;
3. iodine-125 radiant stand standard source to be measured is put into special support survey tool, then put into the ionization chamber of nucleic activity meter, after waiting for for 20 ~ 30 seconds, reading;
4. record the iodine-125 radiant stand standard source radioactivity recorded, measured value and the theoretical value calculated are made comparisons, both errors must within ± 5%;
(2) iodine-125 radiant stand is measured by equivalent activity activity during activity size sub-bottle splendid attire
1. the alignment time is set on request;
2. pick up with tweezers the special activity measurement instrument that an iodine-125 radiant stand puts into iodine-125 radioactivity alimentary stent gently;
3. the survey tool that iodine-125 radiant stand is housed is put into the ionization chamber of nucleic activity meter, the current equivalent activity activity recorded etc. record after stable reading or printing and the equivalent activity activity when the alignment time, put into iodine-125 radiant stand the cillin bottle of corresponding equivalent activity range-of-motion;
2. and 3. 4. above-mentioned steps is repeated until measure and terminate;
(3) equivalent activity activity when user prepares iodine-125 radiant stand is measured as
1. according to equivalent activity activity and the alignment time of user's requirement, the radiant stand in selected roughly satisfactory cillin bottle;
2. pick up with tweezers the special activity measurement instrument that an iodine-125 radiant stand puts into iodine-125 radiant stand gently;
3. the survey tool that iodine-125 radiant stand is housed is put into the ionization chamber of nucleic activity meter, the current equivalent activity activity recorded etc. record after stable reading or printing and the equivalent activity activity when the alignment time, put into the cillin bottle of corresponding equivalent activity range-of-motion by iodine-125 radiant stand; Measure the activity of each radiant stand;
4. press the sign time on label, if the equivalent activity activity of single radiant stand should be 95.0 ~ 105.0%(of sign activity within this equivalent radioactivity scope, then put into wrapping cillin bottle or other suitable vessels; If not within the scope of this, then return in original bottle);
2. and 3. 5. above-mentioned steps is repeated, until pick out the iodine-125 radiant stand of user's Order Quantity;
6. protocol or print data are preserved;
(4) statistics and analysis iodine-125 radiant stand experimental data
1. adopt previous process to produce iodine-125 radiant stand, the radioactivity iodine-125 solution total amount wherein dropped into is all 75mCi, and is normalized on the same day by final activity correction, and gained 15 groups of data are as shown in table 1:
Table 1
；
2. data analysis: each group of data result of the above-mentioned iodine-125 radiant stand produced shows:
A. the utilization rate of radioactivity iodine-125 nucleic is:
71881÷75000×100%=95.8%
Show, radioactivity iodine-125 solution makes radiant stand in employing silica gel production technology, and its nucleic utilization rate is very high;
B. no matter described radiant stand length is how many, only need smear iodine-125 and silica-gel mixture length is certain, the equivalent activity activity of then final radiant stand remains unchanged substantially, and (as: radiant stand length is respectively 40mm, 50mm, 60mm, smearing iodine-125 and silica-gel mixture length, to be 20mm constant, if the target activity of the radiant stand of preparation is simultaneously 2mCi, table 1 data show, three radiant stands are 9.5% to the maximum error of target activity, show that the target activity of producing can reach and the uniformity is fine;
C. along with radiant stand smears iodine-125 and silica-gel mixture length increases, the final equivalent activity activity of radiant stand increases on year-on-year basis, and the maximum outside diameter of described radiant stand is all less than 3.5mm, can meet clinical operation requirement completely;
D. described iodine-125 radiant stand is because smearing radionuclide, do not need radioactive particle " binding " mode on radiant stand adopting the noble metal of the import such as filamentary silver, titanium pipe to make, greatly save the cost of radiant stand, also reduce the complexity of radiant stand " binding "; Simultaneously because of the self-absorption effect that the radioactive shielding of metal pair produces, if therefore prepare the radiant stand of equal activity, more iodine-125 solution need be dropped into, cause the waste of raw material, the increasing the weight of of the increase of cost and environmental pollution; In addition, also because described radiant stand adopts the mode of smearing to prepare, make its increased radioactivity more even, better to the therapeutical effect of tumor;
E. iodine-125 radiant stand can not only ensure effective bile, pancreatic juice drainage, and the accurate radiotherapy effect also by local is treated tumor.
7, applied code
(1) iodine-125 radioactive solution
[character] this product is colourless clear liquid;
It is appropriate that [discriminating] gets this product, and measure according to gamma ray spectrometer method (Pharmacopoeia of People's Republic of China version annex Ⅹ III in 2010), the energy of its primary photon is 35.5KeV, 31.4KeV and 27.4KeV;
It is appropriate that [radionuclide purity] gets this product, measures according to gamma ray spectrometer method (Pharmacopoeia of People's Republic of China version annex Ⅹ III in 2010);
125i content is not less than 99.9%,
126i content should lower than 0.01%.Separately get this product appropriate, detect with liquid scintillation counter, this product should not launch α, Beta-ray radionuclidic impurities containing other;
[radioactive concentration] gets this product, and measure according to radioactive concentration measurement method (Chinese people the Republic of China and state's pharmacopeia version annex Ⅹ III in 2010), the radioactivity of every 1ml should be not less than 29600MBq;
(2) medical silica-gel
[outward appearance] white clear liquid, colorless and odorless.
[performance] meets the medical silica-gel standard that country uses about human body.
(3) this product is iodine-125 radiant stand; Biodegradable pancreatic duct is as support, and the internal layer of involucrum is that skin is medical silica-gel, seals containing the homogeneous mixture of radionuclide iodo-125 with medical silica-gel;
[appearance character] gets this product, and by amplification imaging systems inspection, this product should seal atresia, outer surface flat smooth;
[size] gets this product, and detect with slide gauge or other suitable instruments, the stent length of this product and radioactivity are smeared length and determined according to patient's size of tumor by doctor, and external diameter should be 4.3 ± 0.2mm;
[nuclide identification] gets this product, according to method inspection under [radionuclide purity] item,
125the Characteristic gamma photon energy of I nucleic is 27.4KeV, 31.4KeV, 35.5KeV;
[radionuclide purity] gets 1, this product support, gets its involucrum, soaks 15 minutes (if necessary, can be ultrasonic 10 minutes), get suitable quantity of water solution and make sample, measure according to gamma ray spectrometer method (Pharmacopoeia of People's Republic of China version annex Ⅹ III in 2010) in water;
125i content should be not less than 99.9%,
126i impurity content must not cross 0.01%.Separately get above-mentioned aqueous solution appropriate, with liquid flashing counting determining, α, Beta-ray radionuclidic impurities should not be launched containing other;
[specification] iodine-125 radioactive sealed support; 37 ~ 740MBq (1 ~ 20mCi); Maximum outside diameter is less than 3.5mm;
[packaging and storage] this product inner packing is vial, is equipped with Pastic screw top; Outer package is plumbous safety can processed (or having the rustless steel safety can of equal protection effect); Outer package should meet the requirement of the packaging of " GB11806-89 " I, and the greatest irradiation level of surperficial any point must not be greater than 0.5mR/h; Vial and the outer label of plumbous safety can processed;
This product should under the condition meeting radioactive substance storage, room temperature preservation;
The transport of [transport] this product is carried out according to China and international relevant regulations, and use the carton meeting commodity inspection standard, carton external application has package grade mark and ionizing radiation mark; The following files sends to user with package: product description, quality inspection testimonial, product related data and other required files;
[effect duration] tentative 6 months;
(4) material balance
1. iodine [
125i] change sodium solution utilization rate:
Utilization rate %=(adding iodine-125 activity in iodine-125 total activity-residue)/add iodine-125 total activity × 100%
The utilization rate of radioactivity iodine-125 solution is not less than 95%;
2. shelf appeal: under the condition meeting radioactive substance storage, room temperature preservation.
8, packaging operation
(1) packaged form: iodine-125 radiant stand is contained in be had in the vial of lid, label on bottle, and content comprises: specification, total activity, calibration date, quantity, model and sale numbering; Glass bottle is in the sealed lead safety can having similar tags;
(2) packaging material: vial and lead protection tank.
9, points for attention
(1) instrument and supplies palpus empirical tests, to guarantee the safe and effective of product;
(2) rational deployment, takes positive effective measures preventing pollution and mistake;
(3) the strict purification condition controlling purifying area, guarantees that all technical of purifying area conforms with the regulations;
(4) workman can be on duty after having to pass through training;
(5) strictly press post operation code to produce;
(6) production equipment is forbidden overtemperature, superpressure, over loading and is operated with failure;
(7) staff enters restricted area, observe the safety management code of radioactivity restricted area;
(8) according to work post needs, supply the labor protection product such as each post person works's clothing, cap, footwear, glove, mask, and be equipped with corresponding protective equipment;
(9) operation room epidemic disaster is suitable for, and ventilation installation is good.
Claims (10)
1. treat a radiant stand for malignant tumor of digestive tract, it is characterized in that, be made up of alimentary stent (1), internal layer (2), outer (3) and positioning pipe sleeve (4); Described alimentary stent (1) is smeared internal layer (2), locating sleeve (4) is established in internal layer (2) both sides, described skin (3) wrapping inner layer (2) and locating sleeve (4);
Wherein,
Described internal layer (2) adopts biocompatible polymer material and radioactive substance mixture to prepare;
Described skin (3) is biocompatible polymer material;
Described locating sleeve (4) adopts rustless steel preparation.
2., by the radiant stand for the treatment of malignant tumor of digestive tract according to claim 1, it is characterized in that, described biocompatible polymer material is selected from any one in silica gel, latex, or any two copolymers of above-mentioned material, or the copolymer of three kinds.
3., by the radiant stand for the treatment of malignant tumor of digestive tract according to claim 1, it is characterized in that, described radioactive substance is the radioactive substance half-life being less than 3 months.
4. by the radiant stand of described treatment malignant tumor of digestive tract arbitrary in claim 1 ~ 3, it is characterized in that, internal layer (2) adopts silica gel and radioactivity iodine-125 mixture to prepare.
5., by the radiant stand of described treatment malignant tumor of digestive tract arbitrary in claim 1 ~ 3, it is characterized in that, described skin (3) is silica gel.
6. treat the preparation method of the radiant stand of malignant tumor of digestive tract described in claim 1, it is characterized in that, step is:
(1) liquid-state silicon gel 1 and silica gel 2 are got two equivalent to mix in beaker;
(2) getting appropriate normal octane adds in the mixture of above-mentioned silica gel, by three's mix homogeneously, forms mixture A, stand-by;
(3) adopt the method preparating mixture B same with above-mentioned steps (2), wherein, the normal octane added in mixture B is the twice of addition in mixture A;
(4) needed by described alimentary stent both sides, labelling iodine-125 radioactive position to establish two marks I, and establish mark II in the outside of these two marks I;
(5) with special elasticity pipe cap, support two ends are closed, pollute in order to avoid radioactive substance enters pancreas digestive tract inside;
(6) said mixture A, mixture B and alimentary stent are moved in the glove box with protection of sealing;
(7) size of the iodine-125 radiant stand activity prepared as required, adds the iodine-125 solution of high concentration in mixture B, and again by all substances mix homogeneously;
(8) the described mixture B that takes a morsel is positioned on microscope slide;
(9) with the hands hold the two ends of described support, roll back and forth gently on the microscope slide being placed with mixture B, the mixture B smeared up does not exceed the external boundary of two marks I;
(10) above-mentioned steps (8) and (9) is repeated, by mixture B uniform application in the position that described mark 1 limits;
(11) dry being coated with the described stentplacement wiped at the temperature of 70 degree;
(12) two rustless steel pipe boxes are positioned over mark I place respectively and are close to coating, for CT scan location and postoperative CT scan inspection in performing the operation;
(13) the described mixture A that takes a morsel is placed on another block microscope slide;
(14) two ends of above-mentioned support are with the hands held, roll back and forth on the microscope slide being placed with mixture A gently, the mixture A smeared up covers between mark II, that is smeared first time all seals containing iodine-125 radioactivity mixed zone and rustless steel positioning pipe sleeve, prevents radioactive substance from revealing;
(15) above-mentioned steps (12) and (13) is repeated, by mixture A uniform application in the position that described mark II limits;
(16) again drying being coated with under the above-mentioned support wiped is placed on the temperature of 70 degree, making the radiant stand for the treatment of malignant tumor of digestive tract.
7. by preparation method according to claim 6, it is characterized in that, in described step (4), mark I is 0.5-1cm with the distance of mark II.
8., by preparation method according to claim 6, it is characterized in that, in described step (7), the specific activity of iodine-125 solution is greater than 800mCi/ml.
9., by preparation method according to claim 6, it is characterized in that, in described step (9), the thickness smearing mixture B is 0.2-0.3mm.
10., by preparation method according to claim 6, it is characterized in that, in described step (14), the thickness smearing mixture A is 0.2-0.3mm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310372723.XA CN104414777A (en) | 2013-08-25 | 2013-08-25 | Radioactive bracket for treating malignant tumor of digestive tract and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310372723.XA CN104414777A (en) | 2013-08-25 | 2013-08-25 | Radioactive bracket for treating malignant tumor of digestive tract and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111449803B (en) * | 2020-04-16 | 2021-06-01 | 清华大学 | Drug-loaded artificial rectum for transplantation and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111449803B (en) * | 2020-04-16 | 2021-06-01 | 清华大学 | Drug-loaded artificial rectum for transplantation and preparation method thereof |
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